at Labcorp in Dover, Delaware, United States
Labcorp Drug Development are seeking a Pharmacokineticist to join our Clinical Pharmacology Services department. This position can be home-based anywhere in the U.K., France, the U.S. or Canada. The Pharmacokineticist is responsible for Analysing and reviewing data and offering scientific advice.
Your duties will include but not be restricted to:
+ Fulfill the role of a study Pharmacokineticist:
+ Responsible for PK deliverables within assigned projects.
+ Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK analysis and study objectives.
+ Responsible for development of PK Analysis Plans, to include methodology, definition of derived variables, and data-handling rules.
+ Conduct or review/QC interim PK analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.
+ Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.
+ Conduct modeling/simulation of PK, PD, and PK/PD data and provide interpretation of the results.
+ Responsible for PK input to reports including Clinical Study Reports.
+ Independent peer review of PK and PD deliverables (e.g., protocols, Analysis, Plans, PK reports, Clinical Study Reports).
+ Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.
+ Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines’ activities and participate in interdepartmental processes.
+ Project management activities for identified projects including financial, resource planning and utilization, timelines, and milestone management.
+ Represent Pharmacokinetics in internal and external audits.
+ Supervision and training of less-experienced Pharmacokineticists within project activities.
+ Contact with client across multiple disciplines.
+ Contribute to proposal activities and client presentations.
Get ready to redefine what’s possible and discover your extraordinary potential at Labcorp Drug Development. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us and discover why Labcorp Drug Development has been named by FORTUNE as one of the World’s Most Admired Companies 2021 for the third consecutive year and more than 90% of the top 20 global pharmaceutical companies are repeat customers. We can offer you not only a job, but a stable, long-term international career.
+ Bachelor’s degree in Bioanalytical Chemistry or a Biological Life Sciences degree required.
+ 5 years of postgraduate experience in the application of PK and PD to clinical trials for employees with a BSc in the field of Bioanalytical Chemistry or a Biological Life Sciences Degree.
+ Proficient in compartmental /non-compartmental data analysis.
+ Knowledge of sophisticated PK analysis tools such as WinNonLin and NONMEM.
+ Effective interpersonal and communication skills.
+ Cooperative, team-oriented and proactive.
+ The ability to work to tight deadlines while maintaining high standards.
+ Ability to adhere to strict guidelines and codes of practice.
+ A good knowledge of Clinical Development.
+ Competence in the preparation of Pharmacokinetic Analysis Plans, analysis, reporting, etc., across a variety of trials.
+ Ability to explain PK and PD concepts to non-pharmacokineticists.
+ An evident appreciation of the possible impact of day-to-day activities and actions on Labcorp as a business.
+ A professional approach at all times.
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